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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K884328
Device Name CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE)
Applicant
Select Sources, Inc.
P.O. Box 25b01
Los Angeles,  CA  90025
Applicant Contact ALLEN S FARSHI
Correspondent
Select Sources, Inc.
P.O. Box 25b01
Los Angeles,  CA  90025
Correspondent Contact ALLEN S FARSHI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/14/1988
Decision Date 04/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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